Product code HCF
- Device name
- Instrument, Ligature Passing And Knot Tying
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150882 | Edwards Suture Fastening System | Edwards Lifesciences, LLC | 2015-06-16 |
| K931379 | MICROVASIVE INSURG LAPTIE SUTURE LIGATOR | Boston Scientific Corp | 1993-07-13 |
| K851452 | VALTRAC PURSESTING DEVICE | Davis & Geck, Inc. | 1985-06-12 |
| K841617 | STROVER HOOK | Plastafil, Inc. | 1984-08-27 |
| K790577 | HEMORRHOIDAL LIGATOR | J. Sklar Mfg. Co., Inc. | 1979-04-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G453521053112M0 | PEAK MEDICAL | Peak Medical Distribution Inc. | 2025-10-01 |
| 08904332600766 | Mediflex | ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED | 2025-05-19 |
| 10888277368309 | MEDLINE RENEWAL | MEDLINE INDUSTRIES, INC. | 2025-01-29 |
| 14026704736321 | WECK | TELEFLEX INCORPORATED | 2023-08-16 |
| 10840143909443 | Lariat RS | ATRICURE, INC. | 2023-04-06 |
| 14026704738042 | WECK | TELEFLEX INCORPORATED | 2022-07-15 |
| 14026704738035 | WECK | TELEFLEX INCORPORATED | 2022-07-08 |
| 10840143904424 | Lariat RS | ATRICURE, INC. | 2021-07-29 |
| 10811955020718 | OverStitch Endoscopic Suturing System Sx | Apollo Endosurgery, Inc. | 2021-05-26 |
| 10840143901713 | Lariat RS | ATRICURE, INC. | 2021-01-11 |
| 14026704645289 | WECK | TELEFLEX INCORPORATED | 2020-05-12 |
| 14026704645296 | WECK | TELEFLEX INCORPORATED | 2020-05-11 |
| 09349967000694 | Port ClosOR Pro | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000519 | Suture PassOR | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000540 | Suture PassOR | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000571 | Suture PassOR Pro | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000632 | Suture PassOR Pro | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000366 | Suture PassOR Pro | THE O R COMPANY PTY LTD | 2019-03-26 |
| 14026704645272 | WECK | TELEFLEX INCORPORATED | 2019-01-24 |
| 10381780043294 | ACHILLON® | NEWDEAL | 2018-10-16 |
| 10381780043300 | ACHILLON® | NEWDEAL | 2017-10-05 |
| 10649111297144 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111296703 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111293771 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111292880 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111288531 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111287893 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111287282 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 14026704553263 | WECK | TELEFLEX INCORPORATED | 2016-09-18 |
| 14026704553270 | WECK | TELEFLEX INCORPORATED | 2016-09-18 |